Packaged medical trays



June 23, 1964 A. HARAUTUNEIAN 3,138,253

PACKAGED MEDICAL TRAYS Filed Dec. 27, 1960 United States PatentPharmaseal Laboratories, Glendale, Calif, a corporation of CaliforniaFiled Dec. 27, 1960 Ser. No. 73,497 Claims. (Cl. 206--63.2)

This invention relates to packaged medical trays, and particularly tosterile, disposable trays for use in catheterization procedures.

In the performance of various procedures, hospitals use sterile trayscontaining all of the desired equipment for performing the procedure.For example, such trays may be used for determining venous pressure, formaking exchange transfusions, for making spinal taps, for surgicalpreparation, or for catheterization. Heretofore, these trays wereusually made up by the hospital and after each use, the trays andequipment were cleaned, repacked and sterilized for subsequent use.Since many such procedures are performed in each large hospital, thecleaning, repacking and sterilizing operations take a great deal of timeand labor. Handling contaminated equipment during cleaning operations ishazardous and unpleasant to hospital personnel. Re-use of the equipmentmay cause cross infection between patients, even when the equipment iscarefully cleaned. Many hospitals are not equipped to accuratelydetermine the costs of such work with the result that they mayunknowingly be operating at a loss or overcharging the patient.Furthermore, the trays are completely impractical for home or oiliceuse.

It has been suggested that trays containing disposable equipment beassembled, wrapped and sterilized in factories where adequateprecautions may be taken and tests may be made to assure cleanliness,sterility, and U proper function. Such trays would be discarded after asingle use, thus eliminating the problems of cleaning and It istherefore an object of this invention to provide an improved sterile,disposable tray.

Another object of the invention is to provide a sterile, packaged,disposable tray for urethral catheterization which is compact and easyto ship and store.

A further object of the invention is to provide a packaged,commerdaily-manufactured, gas-sterilizable catheterization tray in aninexpensive package which will assure maintenance of sterility duringshipping and storage.

A still further object of the invention is to provide a catheterizationtray in a package which is easy to open in an aseptic manner andwhichallows convenient addition of antiseptic solution before use.

Further features and advantages of the invention will be apparent fromthe following specification and from the drawings, in which:

FIGURE 1 is an exploded view of the invention;

FIGURE 2 is a perspective view of the invention;

FIGURE 3 is a perspective view of the invention in an inverted orupside-down position; 7

FIGURE 4 is a sectional view on the line 4-4 of FIGURE 3; 7

FIGURE 5 is a perspective view similar to FIGURE 2, but after thepackage has been opened;

FIGURE 6 is a sectional viewon the line 6-6 of Patented June 23, 1964trated in the drawings, a catheter tray 11 is enclosed by a cardboardtray or box 12, the sides and ends of which extend slightly. above thesides and ends of tray ll. A card 13, which may carry directions-for-useand other labeling, lies across the open top of tray 11. An overwrap 14,preferably of transparent plastic film, encloses box 12 and card 13,holding the card in place against the top of tray 11.

Tray 11 is preferably molded of a strong, rigid, impactresistant plasticmaterial, such as polypropylene, linear (high density) polyethylene, orpolystyrene, approximately 0.03 to 0.04 inch thick. Tray 11 preferablyhas a rectangular shape defined by side walls 16 and 17 and end walls 1%and 19. A bottom 2i) has ribs 21 and 22 which provide a flatsupport areafor tray 11 and reinforce the tray against possible warping.

The top of tray 11 is open. The opening defined by.

the top surfaces of side walls 16, 17 and end walls 13, 19 is surroundedby an outwardly projecting fiange 23, from which extends a downwardlydepending lip 24. A transverse dividing wall 3% extends across thecontainer to define a main compartment 31. Compartment 31 preferably hasa volume of 800 to 1000 cubic centimeters for adequate storage of urineobtained by the catheterization procedure. Graduations 32 are molded onthe inner surface of side wall 16. A longitudinal dividing wall 33extends from end wall 18 to transverse dividing wall 30, thus definingtwo small compartments 34 and 35.

As received by the hospital, main compartment 31 preferably contains acatheter 49, a packet 41 of lubricant, a fenestrated drape 42 and aprotective undercover 43. Undercover 43 may be made of a laminate ofabsorbent paper with a waterproof plastic backing. In this way, theundercover can absorb small amounts of spilled liquid, while thewaterproof backing prevents such liquids from soaking through to thebedding. Cotton or rayon balls 44 are placed in each of the compartments3d and 35.

Card 13 is preferably made of cardboard and is slightly smaller than theopen endof box 12. Thus card 13 lies across the top flange 23 of tray11, and is held against 51 may be marked Lift Here to encourage theoperator to bend the tab 51 along the scored line- St) to gain access tocompartments 34 and 35.

Overwrap 14 is preferably made of a strong, transparent, plastic filmsuch as a thin polyvinylchloride film or alaminate of polyethylene withcellophane. The film used should be permeable to sterilizing gases andstrong enough to prevent formation of pinholes, punctures or rupturesafter sterilization. Overwrap 14 is wrapped around box 12 so thatoneedge extends longitudinally along the bottom of the box, providing aninner layer 5d (FIGURES 3 and 4). The other edge of overwrap 14 is thenbrought around box l2 to providean outer layer 54 overlapping innerlayer 55. A longitudinal seal 53: is then formed along the length of thebottom of box 12, sealing outer layer 54 to inner layer 55. A portion ofouter layer 54 extends beyond seal 53 to form a loose overlying flap'56. The ends of overwrap 14 are then folded in around the ends 66 and'67 of box 12 and the end s'eals'5'7, 53 formed.

As shown in FIGURE 7, box' 12 is preferably of the V foldup, corner tablock type formed from a fiat cardboard sections 62, 63 separated frombottom section 61 by scored lines 64, 65. Blank 60 also has end sections66 and 67, the latter being separated from bottom 61 by score line 63.

End section 67 has two flaps 69, 70 extending on opposite sides thereof.Each flap 69, 70 has a locking tab 71, 72 adapted to pass through andlock into the slits 73, 74 in side sections 62, 63, respectively, whenthe side and end sections are bent up along the scored lines to form box12. The respective edges of side sections 62, 63 and of end sections 69,70 define notches 75, 76 between said sections. End section 66 hassimilar flaps and locking tabs which are not shown in detail.

The blank structure thus far described has been used for many purposes.However, it is not suitable for sterile medical trays because the sharpcorners of box 12 formed by the bottom and the respective side and endsections tend to puncture overwrap 14. The holes thus formed cannot betolerated in a medical tray which must be kept sterile. I have foundthat this problem can be solved by extending the notches 75, 76 beyondthe scored lines 64, 65 into a portion of the end section 67. Thisremoves a portion of end section 67, thus forming small holes 79, 89 ineach of the bottom corners of the assembled box 12. The corners thusformed by portions of bottom 61 and portions of the respective sidesections 62, 63, fiex inwardly under pressure so that overwrap 14 is notpunctured.

The packaged catheter tray described above can be sterilized with a gas,such as ethylene oxide or a mixture of ethylene oxide and an inert gas.This is generally done by placing the packaged trays in a pressurevessel and evacuating the vessel to a pressure of less than 15 cm. ofmercury. Sterilizing gas is then admitted to the vessel to a total gaugeof about three atmospheres. Steam is then injected into the vessel toadjust the temperature to about 90 to 140 F., and sterilizationaccomplished in 15 to hours. The sterilizing gases pass freely throughgaspermeable overwrap 14 so that the entire contents of the package aresterile. At the end of the sterilization, the sterilizing vessel isvented and the pressure dropped to one atmosphere. Overwrap 14 maintainsthe package contents in sterile condition. I

In use, the tray is placed upside down, as shown in FIGURE 3, on a benchor table and the box 12 and inner overwrap layer 55 held with one hand.The overlying flap 56 is then raised and pulled back to easily open thelongitudinal seal 53, Without contaminating catheter tray 11 or parts ofbox 12 or card 13 which may contact tray 11. The unit may then be turnedover, as shown in FIG- URE 5, and the overwrap 14 pulled back to exposecard 13.

Frequently, antiseptic solution is available at the nursing station, butnot in the room where the catheterization procedure is to be performed.In this case, corner 52 of card 13 is raised, bending the card along thescored or weakened line 50. Antiseptic solution, such as a quaternaryammonium or iodophor solution is then poured directly onto the rayonballs 44 in the compartment 34. Since the scored line 50 is above thetransverse wall or above compartments 34, near wall 30, antisepticsolution does not enter compartment 31 to contaminate urine sampleswhich later may be drawn into the compartment. Card tab 51 is then bentdown over compartments 34 and 35, closing them until the unit is to beused.

To carry out the catheten'zation procedure, box 12 is placed on aconvenient table, and the top card removed. With sterile gloves, theoperator then aseptically removes the protective undercover 43 fromcompartment 31 and positions it under the patient with the absorbentpaper side up. Catheter tray 11 is then aseptically lifted by thedividing walls 30 and 33 and placed on the sterile undercover 43. Thefenestrated drape 42 is then placed in position over the patient andlubricant squeezed from packet 41 onto a portion of undercover 43.Antiseptic solution is then applied by means of the rayon balls incompartment 34, through the opening in the fenestrated drape. Ex-

' stood that structural details of the invention may be varied by thoseskilled in the art, without departing from the spirit of my invention.

I claim:

1. A sterile, packaged, medical tray comprising: a catheter tray havingbottom, side, and end walls, each of said side and end walls terminatingin a top edge lying in a substantially horizontal plane; an open topdefined by the top edges of the respective side and end walls; atransverse wall connecting the two side walls and sep arating the trayinto an antiseptic section near one end of said tray and a maincompartment extending throughout the remaining portion of said tray,said transverse wall having a top edge lying substantially in the planeof the side and end wall top edges; removable antiseptic absorbent meansin the antiseptic section of said tray; a flat card closing the open topof said tray, portions of said card resting on the respective top edgesof the side and end walls, and the top edge of said transverse wall, butbeing free of attachment to said walls; a scored transverse line acrosssaid card, said scored line being parallel to the top edge of saidtransverse wall, being positioned over the antiseptic section andproviding a weakened line of increased flexibility along which the cardis easily bent so as to form a hinged tab over the antiseptic section,said tab allowing the antiseptic section to be selectively opened andclosed without exposing said main compartment; and a film overwrapenclosing said tray and card, said film overwrap holding said card inplace over said tray, being impervious to bacteria, and being providedwith opening means at the end of the tray adjacent the antisepticsection, whereby the overwrap can be pulled back to expose the tab oversaid section while still holding the remaining portion of the card inplace over the main tray compartment.

2. A sterile, packaged, medical tray as set forth in claim 1 whereinsaid overwrap has an overlapped section lying lengthwise along thebottom of the tray; a longitudinal seal along the inner edge of theoverlapped section; and a loose portion of the overlapped section lyingoutwardly of the seal.

3. A sterile, packaged medical tray as set forth in claim 1 wherein thecatheter tray is positioned in a cardboard box and said overwrap isapplied around said tray and said box, said box being of the corner tablock type having a bottom and sides and end walls, at least one cornerformed by adjacent portions of the bottom and the respective side wall,the end and side having a small undercut V-shaped notch at theintersecting corner of the side, end, and bottom of said box to relievethe sharp corner without creating a large hole through the box throughwhich the overwrap could be punctured, said notch appearing on the endmember when the box is in its erected state; and a locking tab on theend wall to fold up and engage a notch within a corresponding side wall.

4. A sterile, packaged, medical tray comprising: a plastic tray havingbottom, side, and end walls, each of said side and end walls terminatingin a top edge to provide an open top; sterile, disposable, medicalinstruments and equipment positioned in said tray; a fold-up, corner tablock-type box in which the tray is positioned, said box having a bottom,side and end walls, and at least one corner formed by a portion of thebottom and of the respective side walls; a flat card closing the opentop of said tray, portions of said card resting on the respective topedges of the side and end walls of the tray; a film-like overwrappervious to sterilizing gases but impervious to bacteria enclosing saidbox and card; and a small V-shaped notch formed by the adjacent end andside sections at each bottom corner of the box, said notch appearing onthe end member of the box, extending into said end member and providinga softened, dulled bottom corner, the film-like overwrap thus beingsupported by the side, end and bottom walls of the box and by the card,but being unsupported at the small notched bottom corner wherebypuncture of the overwrap by the sharp corner usually present in cornertab lock-type boxes is prevented.

5. A sterile, packaged medical tray comprising: a molded, plasticcatheterization tray having side and end walls, a bottom wall and anopen top; a transverse wall dividing said tray into a main compartment,said main compartment having graduations on the inner wall surfacethereof, and an antiseptic section, a partition between said transversewall and the end of said tray separating said antiseptic section intotwo antiseptic compartments, the two antiseptic compartments containingabsorbent means for liquid antiseptic, a flange projecting outwardlyfrom the tray walls around the open top to provide a flat top surface; aflat card lying across said top surface and closing the open top of thetray; said flat card having a score line laterally across it at aposition parallel to but a slight distance from the transverse wall soas to place the score line over the antiseptic section, said score lineproviding a flexible hinge enabling said antiseptic compartments to beselectively opened and closed without opening said main compartment; acardboard box enclosing the tray and having side and end walls extendingslightly above the tray walls; a bottom on said box; a film-likeoverwrap around the box and References Cited in the file of this patentUNITED STATES PATENTS 1,644,830 Henderson Oct. 11, 1927 1,680,804 RemleyAug. 14, 1928 1,907,067 Hartmann May 2, 1933 1,992,098 Sidway Feb. 19,1935 2,055,333 Burke Sept. 22, 1936 2,138,241 Koch Nov. 29, 19382,295,478 Jason Sept. 8, 1942 2,366,419 Meller Jan. 2, 1945' 2,471,861Cahn May 31, 1949 2,934,252 Wickstrom Apr. 26, 1960 2,965,501 HarrissDec. 20, 1960 2,967,383 Rumsey Jan. 10, 1961 2,990,948 Zackheim July 4,1961 3,037,680 Hickin June 5, 1962 3,043,354 Fitzgerald July 10, 19623,059,829 Thompson Oct. 23, 196% 3,062,371 Patience Nov. 6,

5. A STERILE, PACKAGED MEDICAL TRAY COMPRISING: A MOLDED, PLASTICCATHETERIZATION TRAY HAVING SIDE AND END WALLS, A BOTTOM WALL AND ANOPEN TOP; A TRANSVERSE WALL DIVIDING SAID TRAY INTO A MAIN COMPARTMENT,SAID MAIN COMPARTMENT HAVING GRADUATIONS ON THE INNER WALL SURFACETHEREOF, AND AN ANTISEPTIC SECTION, A PARTITION BETWEEN SAID TRANSVERSEWALL AND THE END OF SAID TRAY SEPARATING SAID ANTISEPTIC SECTION INTOTWO ANTISEPTIC COMPARTMENTS, THE TWO ANTISEPTIC COMPARTMENTS CONTAININGABSORBENT MEANS FOR LIQUID ANTISEPTIC, A FLANGE PROJECTING OUTWARDLYFROM THE TRAY WALLS AROUND THE OPEN TOP TO PROVIDE A FLAT TOP SURFACE; AFLAT CARD LYING ACROSS SAID TOP SURFACE AND CLOSING THE OPEN TOP OF THETRAY; SAID FLAT CARD HAVING A SCORE LINE LATERALLY ACROSS IT AT APOSITION PARALLEL TO BUT A SLIGHT DISTANCE FROM THE TRANSVERSE WALL SOAS TO PLACE THE SCORE LINE OVER THE ANTISEPTIC SECTION, SAID SCORE LINEPROVIDING A FLEXIBLE HINGE ENABLING SAID ANTISEPTIC COMPARTMENTS TO BESELECTIVELY OPENED AND CLOSED WIWTHOUT OPENING SAID MAIN COMPARTMENT; ACARDBOARD BOX ENCLOSING THE TRAY AND HAVING SIDE AND END WALLS EXTENDINGSLIGHTLY ABOVE THE TRAY WALLS; A BOTTOM ON SAID BOX; A FILM-LIKEOVERWRAP AROUND THE BOX AND CARD, ONE EDGE OF THE OVERWRAP EXTENDINGLONGITUDINALLY ALONG THE BOTTOM OF THE BOX; A SECOND EDGE OF THEOVERWRAP EXTENDING LONGITUDINALLY ALONG THE BOTTOM OF THE BOX ANDOVERLYING THE FIRST EDGE; A LONGITUDINAL SEAL ALONG THE TWO LAYERS OFOVERWRAP; AND A LOOSE PORTION OF THE SECOND OVERWRAP LAYER OVERLYING THEFIRST LAYER AND EXTENDING BEYOND SAID SEAL, WHEREBY SAID OVERWRAP CAN BEPULLED BACK BY A PART OF SAID LOOSE PORTION TO EXPOSE THE TAB OVER THEANTISEPTIC SECTION WHILE STILL HOLDING THE REMAINDING PORTION OF THECARD IN PLACE OVER THE MAIN TRAY COMPARTMENT.